AUTHORITY: Sec. 1159 of the Social Security Act; sec. 249F, Pub. L. 92-603; 86 Stat. 1429-1445 (42 U.S.C. 1320c-8); sec. 1102 of the Social Security Act, 49 Stat. 647 as amended (42 U.S.C. 1302).

SOURCE: 42 FR 4677, Jan. 25, 1977, unless otherwise noted. Redesignated at 42 FR 52826, Sept. 30, 1977.

§ 473.1 Applicability.

The regulations of this part are applicable to hearings provided by the Secretary pursuant to section 1159(b) of the Social Security Act (hereinafter "the Act") with regard to determinations under section 1155(a) of the Act by a PSRO, including a conditional PSRO, which has assumed full review responsibility in specified health care institutions.

§ 473.2 Right to reconsideration, review and hearing.

(a) Any beneficiary or recipient who is entitled to benefits under the Act (other than Title V), or a provider or practitioner who is dissatisfied with a determination, with respect to a claim, made by a Professional Standards Review Organization in carrying out its responsibilities for the review of professional activities in accordance with paragraphs (1) and (2) of section 1155(a) of the Act shall, after being notified of such determination, be entitled to a reconsideration thereof by the Professional Standards Review Organization, and, where the Professional Standards Review Organization reaffirms such determination in a State which has established a Statewide Professional Standards Review Council, and where the matter in controversy is $100 or more, such determination shall, upon the written request of the dissatisfied party, be reviewed by professional members of such Council and, if the Council so determines, revised.

(b) Where the determination of a Statewide Professional Standards Review Council is adverse to the beneficiary or recipient (or where there is no such Council in a State and where the matter in controversy is $100 or more), such beneficiary or recipient shall be entitled to a hearing thereon

by the Secretary to the same extent as provided in section 205(b) of the Act.

(c) Any review or appeal provided under this section shall be in lieu of any review, hearing or appeal under the Act with respect to the same issue.

§ 473.3 Utilization of procedures under Title XVIII, Part A, hearing procedures.

The procedures specified in §§ 405.722 (time and place of filing request for hearing) and §§ 405.740 through 405.747 (determining amount in controversy), of this chapter, and §§ 404.919 through 404.952 and 404.954 through 404.956 (procedures for conduct of hearings and Appeals Council review); §§ 405.750, 404.958, 404.961 through 404.963, and 404.966 (reopening initial or reconsidered determinations and hearings or Appeals Council decisions); and §§ 404.971 through 404.973 (representation of parties) of Title 20 Code of Federal Regulations, except to the extent inconsistent with specific provisions of this part shall govern hearings under section 1159(b) of the Act.

§ 473.4 Professional consultation.

(a) Any decision made by an Administrative Law Judge with regard to a PSRO determination shall be made only after receiving and considering appropriate professional consultation on the matter.

(b) Professional consultation shall be obtained by the Administrative Law Judge, in the form of either testimony or written opinion, from an impartial medical advisor selected by the Bureau of Hearings and Appeals of the Social Security Administration in each matter which he is to decide under section 1159(b). Such consultation shall be part of the record, and shall be considered by the Administrative Law Judge along with other evidence of record in deciding the issues before him.

(1) Each party shall have the right to examine all evidence of record, including that obtained from the medical advisor, and to present rebuttal evidence. Such rebuttal evidence shall be made part of the record for consideration.

(2) Such consultation shall be rendered by a licensed doctor of medicine or osteopathy whenever the health care services or items in question were provided or proposed to be provided by another licensed doctor of medicine or osteopathy.

(3) No professional advisor shall be utilized to provide such consultation if: (i) He was directly or indirectly involved in providing the services which are the subject of the hearing; (ii) he or any member of his family has, directly or indirectly, any financial interest in the institution in which such services were provided or were proposed to be provided; (iii) he participated in the PSRO initial or reconsidered determinations or the Statewide Council determination which is the subject of the hearing; (iv) he has staff privileges in the institution in which such services were provided or proposed to be provided; (v) he is a member of the governing body of the PSRO or a member of the Statewide Council which rendered a determination in the matter, or (vi) a reasonable showing is made to the Administrative Law Judge that an advisor may be biased with regard to the case under review. Where a professional advisor is rejected, the Administrative Law Judge shall obtain appropriate professional consultation from another professional advisor who meets the requirements of this part.

§ 473.5 Determining amount in controversy in case of proposed services.

Where services or items proposed to be provided have been disapproved by the PSRO, the amount in controversy shall be determined upon the basis of reasonable estimates of the amounts which would be charged the individual if such services or items were provided, and shall be computed in accordance with the principles set forth in § 405.740 of this chapter.

§ 473.6 Right of judicial review.

To the extent authorized by section 1159(b) of the Act, a party to a decision of the Appeals Council (see § 404.950 of 20 CFR), or the decision of an Administrative Law Judge where the request for review by the Appeals Council was denied, may obtain a

474.6

Basis for recommended sanction. 474.7 Notice and review of PSRO determination of violation.

474.8 PSRO report to the Statewide Council or to HCFA.

474.9 Role and functions of the Statewide Council.

474.10 Action by HCFA on receipt of the report.

474.14 Effective dates of exclusion. 474.15

Reinstatement after exclusion. 474.17 Right to judicial review.

AUTHORITY: Secs. 1102, 1157, and 1160(b), Social Security Act (42 U.S.C. 1302, 1320c-6, and 1320c-9).

SOURCE: 45 FR 11438, Feb. 20, 1980, unless otherwise noted.

§ 474.0 Scope and definitions.

(a) Scope. This part implements sections 1157 and 1160 of the Act by:

(1) Setting forth certain obligations imposed on practitioners and providers of services under Medicare and Medicaid;

(2) Establishing criteria and procedures for the reports required from Professional Standards Review Organizations and Statewide Councils when there is failure to meet those obligations;

(3) Specifying the policies and procedures for making determinations on violations and imposing sanctions; and

(4) Establishing policies and procedures for appeals by the affected party or review by HCFA.

compliance with the obligations imposed by section 1160(a) of the Act on practitioners and other providers of health care services for which payment may be made under Title V, XVIII, or XIX of the Act.

(2) In order to carry out this responsibility, the Council shall, in accordance with section 1161(c) of the Act:

(i) Use whatever authority or influence it may possess as a professional organization;

(ii) Enlist the support of other professional or governmental organizations;

(iii) Use educational and other appropriate means; and

(iv) Work cooperatively with PSROS in the State.

(g) Appeals. When an adverse PSRO determination has been reconsidered and reaffirmed pursuant to section 1159(a) of the Act and the amount in controversy is $100 or more, the professional members of each Statewide Council shall review such determination on appeal, in accordance with regulations to be published by the Secretary.

(h) Sanctions. Each Statewide Council shall

(1) Receive reports and recommendations from PSROS under section 1157 of the Act concerning violations of obligations under section 1160(a) of the Act; and

(2) Promptly transmit those reports to the Secretary, with any comments or recommendations they deem appropriate, in accordance with regulations to be published by the Secretary.

(i) Confidentiality of data. (1) The purpose of the confidentiality requirements is to assure adequate protection of the rights and interests of patients, health care practitioners, and providers of health care.

(2) The confidentiality requirements apply to:

(i) Any information acquired by the Statewide Council in the exercise of its own duties and functions or through the exercise of PSRO functions and duties; and

(ii) Sanction reports and recommendations made by the Statewide Council.

(3) The information specified in paragraph (h)(2)(i) of this section

shall not be disclosed to any person except:

(i) To the extent that may be necessary to carry out the purposes of Title XI, Part B of the Act and of this subpart; or

(ii) In cases or circumstances specified in regulations to be published by the Secretary.

§ 478.7 Organizational requirements.

(a) Organization. (1) Each Statewide Council shall be a private, nonprofit corporation established under applicable State law unless another organizational status is approved by the Secretary.

(2) Membership in the corporation shall be limited to members of the Statewide Council.

(3) The Board of Directors shall consist of all persons appointed by the Secretary as members of the Statewide Council.

(b) Articles of Incorporation. The Articles of Incorporation of each Statewide Council and any subsequent amendments thereto, shall be approved by the Secretary prior to filing and shall be in conformance with State law, Title XI, Part B of the Act, and the requirements of this part.

(c) Bylaws. Bylaws of each Statewide Council shall be in conformance with the requirements of this part.

(d) Purposes. The purposes of the Statewide Council shall be limited to those duties and functions specified in § 478.6, except where other functions related to such purposes shall be specifically approved by the Secretary.

(e) Income. (1) The sole sources of income of each Statewide Council shall be (i) the funds paid by the Secretary under section 1162(d) of Title XI of the Act; and (ii) any other sources of funding approved by the Secretary.

(2) Neither the whole, nor any portion of the assets or income of the Statewide Council shall be used for objects or purposes other than those set forth in § 478.6 or those specifically approved by the Secretary.

(f) Officers. Each Statewide Council shall elect a chairperson and such other officers from its membership as it deems necessary.

(g) Committees. (1) Each Statewide Council shall establish an Advisory Group Nominating Committee as provided for under section 1162(e) of the Act.

(2) A Statewide Council may establish an Executive Committee which shall consist of members of the Statewide Council including at least one PSRO representative, one physician representative, and one public

representative.

(3) The composition, selection, powers, duties, and membership terms of each standing committee of a Statewide Council shall be defined in its bylaws. The bylaws shall specify a procedure for the establishment of ad hoc committees.

(4) A Statewide Council may appoint non-Statewide Council members to ad hoc committees, but non-Statewide Council members may not serve as members of Statewide Council standing committees.

(h) Advisory Group. Each Statewide Council shall actively seek advice from its Statewide Council Advisory Group, established pursuant to section 1162(e) of the Act.

(i) Planning PSROs. The Statewide Council may seek advice, regarding Council activities, from any organization within the State that has an agreement with the Secretary to prepare to meet the requirements for designation as a PSRO (section 1169 of the Act).

(j) Executive Secretary. The Statewide Council shall select and appoint an Executive Secretary to be employed on either a full or part-time basis.

§ 478.8 Operational requirements.

(a) Calling of meetings. (1) The Chairperson of each Statewide Council shall convene a meeting of its members at least 4 times a year, and as often as necessary in order to perform those functions specified in § 478.6.

(2) Each Statewide Council shall establish a method for the calling of a special meeting of the full Statewide Council.

(3) Meetings shall be held at a reasonable time and at a reasonable place with an adequate amount of space to allow for public access to, and partici

pation in, said meetings to the extent not inconsistent with the provisions of paragraph (d) of this section.

(b) Quorum and voting. (1) Each Statewide Council shall determine quorum and voting requirements for meetings of the whole Statewide Council and for meetings of the committees consistent with the provisions of State law applicable to the corporation.

(2) For Statewide Council matters there shall be no proxy voting, whereby the voting privilege of one member is exercised by another person.

(c) Notice of meetings. (1) Each Statewide Council shall provide public notice of each of its regular meetings and, to the extent practicable, for each special meeting.

(2) The notice shall indicate at least: (i) The time, date, place, and purpose of the meeting; and

(ii) The extent to which the public will be permitted to attend or participate in the meeting.

(3) If all or part of the meeting is to be closed to the public, the notice shall state the reason for closing.

(d) Public participation at meetings. (1) All or part of Statewide Council meetings shall be open to the public, except when the meeting concerns:

(i) Review of sanction reports or recommendations, forwarded to the Statewide Council pursuant to section 1157 of the Act;

(ii) Review of PSRO reconsiderations pursuant to section 1159(a) of the Act;

(iii) Information which could cause financial injury if disclosed;

(iv) Internal personnel rules and practices of the Statewide Council;

(v) Financial information obtained from a person and privileged or confidential;

(vi) Matters prohibited from disclosure by statute;

(vii) Information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy; and

(viii) Information that, if prematurely disclosed, would be likely to significantly frustrate implementation of a Statewide Council action, unless:

(A) The Council has already disclosed to the public the content or nature of the action; or

(B) The Council is required by law to disclose the information prior to taking final Statewide Council action.

(2) Before or after a meeting, members of the public shall be permitted to file written statements with the Statewide Council.

(3) To the extent that the time available permits, and subject to the chairperson's approval for such participation, members of the public may make oral statements during the meeting.

(e) Conflicts of interest. (1) Each Statewide Council shall establish a procedure for announcing and deciding upon conflicts of interest. This procedure shall be specified in the bylaws.

(2) Restrictions on the participation of Statewide Council members in review of PSRO reconsiderations pursuant to section 1159(a) of the Act and in the review of Sanction reports pursuant to section 1157 of the Act are provided in Part 473 and regulations to be issued by the Secretary.

(f) Summaries of proceedings. (1) Summaries of proceedings of all meetings of the Statewide Council and of meetings of its standing and ad hoc committees shall be prepared promptly.

(2) The completed summaries shall be certified for accuracy by the chairperson of the Statewide Council or the chairperson of the committee, as appropriate, within a reasonable time after each meeting.

(3) The summaries shall be available to the public for inspection and copying at the office of the Statewide Council during regular business hours consistent with the confidentiality requirements of section 1166 of the Act and regulations to be issued by the Secretary.

§ 478.9 Reporting requirements.

(a) Each Statewide Council shall prepare and submit to the Secretary annually a report containing the following information:

(1) The organizational structure of the Statewide Council during the year for which the report is made.

(2) The Statewide Council's activities for the year including a summary of meetings, a description of specific projects, and any recommendations. (3) Description of goals and projects for the coming year.

information

(4) Other pertinent which the Secretary may reasonably require.

(b) Each Statewide Council shall make such regular and special reports, in addition to the report required by paragraph (a) of this section, in such form and containing such information as the Secretary may reasonably require.

§ 478.10 Statewide Council Agreements.

(a) The Secretary will enter into an agreement with each Statewide Council appointed in accordance with this part.

(b) Each Statewide Council agreement shall provide that:

(1) The organization is designated by the Secretary as the Statewide Council for a particular State;

(2) The organization will perform all the duties and functions of Statewide Council under Title XI, Part B of the Act and the applicable regulations of this subchapter;

(3) The Secretary will make payments to the Statewide Council equal to the amount of expenses it has reasonably and necessarily incurred in carrying out the duties and functions specified in Part B of Title XI of the Act and in this part.

(4) The reasonableness and necessity of incurred expenditures and the reimbursement policies will be determined by the Secretary.

(5) The organization will establish an advisory group pursuant to section 1162 (e) of the Act; and

(6) The agreement may be terminated by the Secretary upon 90 days notice to the Statewide Council.1

1Attention is called to the requirements of Executive Order 11246 (42 U.S.C. 2000e) which prohibits discriminating against any employee or applicant for employment because of race, color, religion, sex or national origin. Regulations implementing such Executive Order 11246, which are applicable to Statewide Councils under this subpart, have been issued by the Secretary of Labor (41 CFR Chapter 60).